Thirty Respiratory receives approval for multicentre post-exposure clinical trial of RESP301 to prevent transmission of COVID-19 in the community

Break-through new treatment to protect people at risk from COVID-19
London, UK, 15 January 2021.
Thirty Respiratory (“30 Technology”) announces that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved its application to conduct a multicentre, open label clinical study of an inhaled nitric oxide generating solution (RESP301) in up to 600 people in the community with COVID-19 or at risk of the infection.

“With the PREVENT study we are taking a major step forward in being able to stop the transmission of COVID-19 and emerging strains of the virus” said Syd Hanna, 30 Technology’s Executive Director. He added “The initial safety and tolerability seen in our hospitalised study presents the opportunity to bring our treatment to many more patients who have symptoms or have tested positive, as well as protect those who are in close contact. This could be a major advance in dealing with the current and future pandemics.”

The study’s Chief Investigator, Professor Onn Min Kon, Professor of Respiratory Medicine at Imperial College, London, said “Although vaccines will be critical in the fight against COVID-19, we still urgently need an effective way of preventing infection and treating the thousands of people testing positive every day, and RESP301 has the potential to meet that need.”

RESP301 is a nitric oxide (NO) generating medication that the patient inhales from a simple hand-held nebuliser. The fine particle droplets release NO into the lungs and upper airways. NO is produced normally in healthy lungs and is the first line of defence against viral or bacterial infection. RESP301 replenishes the NO and helps boost the body’s immune system. A huge advantage of the NO produced by RESP301 is that it remains effective even against the new variants of the virus.

People in close contact with test-positive individuals, or those with symptoms, are at higher risk of contracting the infection. The aim of this current study is to assess a targeted public health intervention with a short course of an antiviral drug given to index cases testing positive for CoV-2 / other respiratory viruses and their household members. The intention is to prevent onward transmission of the viral respiratory infection within households by (i) reducing the viral transmission by the index case, and (ii) post-exposure prophylaxis (PEP) of the household members.
The patients will be recruited initially in the Greater London area, and the trial is expected to expand to many other areas of the country. Dr Sarah Elkin, the study’s Principal Investigator said “We have to stop transmission of the virus if we are to defeat this serious infection. To do that we need to treat the infected patient and protect those at risk who are in close contact with them. We are hopeful that RESP301 will do that for us”.

About RESP301

RESP301 is a NO-generating liquid designed to release NO in situ in the upper airways and deep in the alveolar spaces. RESP301 is an admixture solution of two precursor solutions mixed at point of care for immediate inhaled administration via a handheld nebuliser and has specific advantages in treating a range of respiratory viruses, including SARS-CoV-2. In laboratory testing, RESP301 has also demonstrated potent activity against various influenza virus strains, rhinovirus and coronavirus. It has also shown high in vitro activity against other respiratory pathogens, both viral and bacterial. The novel concept for RESP301 is that it will restore the levels of NO in the lungs with a dual action of both killing virus and bacteria and boosting the host response against these pathogenic microbes.

About 30 Technology

30 Technology is a privately owned biopharmaceutical company developing proprietary NO-generating technologies. The products that 30 Technology has developed have very broad application in many areas of medicine. Efficacy of the technology has been confirmed in large-scale clinical trials1, and in the laboratory2. A dermatology treatment using the NO-generating technology has been shown to have better and faster healing of diabetic foot ulcers than the current standard of care for this condition1.

The NO-generating solution being used in 30 Technology’s CORVIS and NOCoV2 studies has even greater potential in other common viral respiratory infections and many lung conditions for which infection is a major cause of morbidity and mortality.

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1 Edmonds ME, Bodansky HJ, Boulton AJM, Chadwick PJ, Dang CN, D’Costa R et al. Multicenter, randomized controlled, observer-blinded study of a nitric oxide generating treatment in foot ulcers of patients with diabetes-ProNOx1 study. Wound Repair Regen. 2018; 26(2):228-237.

2 Waite RD, Stewart JE, Stephen AS, Allaker RP. Activity of a nitric oxide generating wound treatment system against wound pathogen biofilms. Int J Antimicrob Agents.2018; 52(3):338-343.

30 TECHNOLOGY is developing and defining new models of care to treat many serious medical conditions by enhancing the body’s healing and defence mechanisms.

30 TECHNOLOGY Therapeutic Nitric Oxide